EP2986216B1 - Medical device for collection of a biological sample - Google Patents
Medical device for collection of a biological sample Download PDFInfo
- Publication number
- EP2986216B1 EP2986216B1 EP14722948.8A EP14722948A EP2986216B1 EP 2986216 B1 EP2986216 B1 EP 2986216B1 EP 14722948 A EP14722948 A EP 14722948A EP 2986216 B1 EP2986216 B1 EP 2986216B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- reservoir
- biological fluid
- lumen
- interior
- sampling device
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000012472 biological sample Substances 0.000 title description 2
- 238000005070 sampling Methods 0.000 claims description 108
- 239000012530 fluid Substances 0.000 claims description 62
- 239000013060 biological fluid Substances 0.000 claims description 49
- 230000002792 vascular Effects 0.000 claims description 37
- 238000004891 communication Methods 0.000 claims description 28
- 239000003381 stabilizer Substances 0.000 claims description 8
- 238000003780 insertion Methods 0.000 claims description 6
- 230000037431 insertion Effects 0.000 claims description 6
- 230000000007 visual effect Effects 0.000 claims description 4
- 239000012528 membrane Substances 0.000 claims description 3
- 230000006835 compression Effects 0.000 claims description 2
- 238000007906 compression Methods 0.000 claims description 2
- 238000002955 isolation Methods 0.000 claims description 2
- 239000008280 blood Substances 0.000 description 90
- 210000004369 blood Anatomy 0.000 description 90
- 239000000523 sample Substances 0.000 description 75
- 238000012360 testing method Methods 0.000 description 48
- 238000010241 blood sampling Methods 0.000 description 34
- 238000000034 method Methods 0.000 description 21
- 238000012123 point-of-care testing Methods 0.000 description 17
- 239000000126 substance Substances 0.000 description 10
- 230000008569 process Effects 0.000 description 9
- 239000003755 preservative agent Substances 0.000 description 8
- 238000001990 intravenous administration Methods 0.000 description 7
- 238000009534 blood test Methods 0.000 description 6
- 230000002335 preservative effect Effects 0.000 description 6
- 230000000717 retained effect Effects 0.000 description 6
- 239000011521 glass Substances 0.000 description 5
- 239000000463 material Substances 0.000 description 4
- 230000015271 coagulation Effects 0.000 description 3
- 238000005345 coagulation Methods 0.000 description 3
- 239000003792 electrolyte Substances 0.000 description 3
- -1 hematology Substances 0.000 description 3
- 208000004476 Acute Coronary Syndrome Diseases 0.000 description 2
- 206010051055 Deep vein thrombosis Diseases 0.000 description 2
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
- 239000003146 anticoagulant agent Substances 0.000 description 2
- 229940127219 anticoagulant drug Drugs 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 239000003153 chemical reaction reagent Substances 0.000 description 2
- 238000002405 diagnostic procedure Methods 0.000 description 2
- 239000008103 glucose Substances 0.000 description 2
- 230000002209 hydrophobic effect Effects 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 230000002093 peripheral effect Effects 0.000 description 2
- 239000005020 polyethylene terephthalate Substances 0.000 description 2
- 229920000139 polyethylene terephthalate Polymers 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- 238000013022 venting Methods 0.000 description 2
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 1
- HTTJABKRGRZYRN-UHFFFAOYSA-N Heparin Chemical compound OC1C(NC(=O)C)C(O)OC(COS(O)(=O)=O)C1OC1C(OS(O)(=O)=O)C(O)C(OC2C(C(OS(O)(=O)=O)C(OC3C(C(O)C(O)C(O3)C(O)=O)OS(O)(=O)=O)C(CO)O2)NS(O)(=O)=O)C(C(O)=O)O1 HTTJABKRGRZYRN-UHFFFAOYSA-N 0.000 description 1
- WHXSMMKQMYFTQS-UHFFFAOYSA-N Lithium Chemical compound [Li] WHXSMMKQMYFTQS-UHFFFAOYSA-N 0.000 description 1
- 229920001410 Microfiber Polymers 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 208000010378 Pulmonary Embolism Diseases 0.000 description 1
- 229920000690 Tyvek Polymers 0.000 description 1
- 206010047249 Venous thrombosis Diseases 0.000 description 1
- 230000000712 assembly Effects 0.000 description 1
- 238000000429 assembly Methods 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 229910052791 calcium Inorganic materials 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 229960002897 heparin Drugs 0.000 description 1
- 229920000669 heparin Polymers 0.000 description 1
- 238000010102 injection blow moulding Methods 0.000 description 1
- 238000001746 injection moulding Methods 0.000 description 1
- 229910052500 inorganic mineral Inorganic materials 0.000 description 1
- 229910052744 lithium Inorganic materials 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 239000003658 microfiber Substances 0.000 description 1
- 239000011707 mineral Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 229920002994 synthetic fiber Polymers 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150213—Venting means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/14—Devices for taking samples of blood ; Measuring characteristics of blood in vivo, e.g. gas concentration within the blood, pH-value of blood
- A61B5/1405—Devices for taking blood samples
- A61B5/1411—Devices for taking blood samples by percutaneous method, e.g. by lancet
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150015—Source of blood
- A61B5/150022—Source of blood for capillary blood or interstitial fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150221—Valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150267—Modular design or construction, i.e. subunits are assembled separately before being joined together or the device comprises interchangeable or detachable modules
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
- A61B5/150305—Packages specially adapted for piercing devices or blood sampling devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150343—Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150748—Having means for aiding positioning of the piercing device at a location where the body is to be pierced
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150763—Details with identification means
- A61B5/150778—Details with identification means having complementary physical shapes for indexing or registration purposes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15101—Details
- A61B5/15103—Piercing procedure
- A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15142—Devices intended for single use, i.e. disposable
- A61B5/15144—Devices intended for single use, i.e. disposable comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
- A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
- A61B5/15188—Constructional features of reusable driving devices
- A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
- A61B5/15198—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing purely manually retracted
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5021—Test tubes specially adapted for centrifugation purposes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
- B04B—CENTRIFUGES
- B04B7/00—Elements of centrifuges
- B04B7/08—Rotary bowls
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/34—Purifying; Cleaning
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/4005—Concentrating samples by transferring a selected component through a membrane
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/4077—Concentrating samples by other techniques involving separation of suspended solids
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
- G01N33/491—Blood by separating the blood components
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
- A61B5/150435—Specific design of proximal end
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150007—Details
- A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
- A61B5/150381—Design of piercing elements
- A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/15—Devices for taking samples of blood
- A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/06—Fluid handling related problems
- B01L2200/0631—Purification arrangements, e.g. solid phase extraction [SPE]
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
- B01L2200/10—Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/06—Auxiliary integrated devices, integrated components
- B01L2300/0681—Filter
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/04—Moving fluids with specific forces or mechanical means
- B01L2400/0475—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure
- B01L2400/0478—Moving fluids with specific forces or mechanical means specific mechanical means and fluid pressure pistons
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/4005—Concentrating samples by transferring a selected component through a membrane
- G01N2001/4016—Concentrating samples by transferring a selected component through a membrane being a selective membrane, e.g. dialysis or osmosis
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/40—Concentrating samples
- G01N1/4077—Concentrating samples by other techniques involving separation of suspended solids
- G01N2001/4088—Concentrating samples by other techniques involving separation of suspended solids filtration
Definitions
- the present invention relates to devices, assemblies, and systems adapted for use with vascular access devices, for collecting biological samples for use in point-of-care testing, and for filling specimen collection containers for use in conventional laboratory testing.
- Blood sampling is a common health care procedure involving the withdrawal of at least a drop of blood from a patient.
- Blood samples are commonly taken from hospitalized, homecare, and emergency room patients either by finger stick, heel stick, or venipuncture. Once collected, blood samples may be analyzed to obtain medically useful information including chemical composition, hematology, coagulation, etc.
- Blood tests determine the physiological and biochemical states of the patient, such as disease, mineral content, drug effectiveness, and organ function. Blood tests may be performed in a clinical laboratory or at the point-of-care near the patient.
- One example of point-of-care blood testing is the routine testing of a patient's blood glucose levels which involves the extraction of blood via a finger stick and the mechanical collection of blood into a diagnostic cartridge. Thereafter, the diagnostic cartridge analyzes the blood sample and provides the clinician a reading of the patient's blood glucose level.
- Other devices are available which analyze blood gas electrolyte levels, lithium levels, and ionized calcium levels. Some other point-of-care devices identify markers for acute coronary syndrome (ACS) and deep vein thrombosis/pulmonary embolism (DVT/PE).
- ACS acute coronary syndrome
- DVD/PE deep vein thrombosis/pulmonary embolism
- Blood samples are frequently drawn using hypodermic needles or vacuum tubes attached to a proximal end of a needle or a catheter assembly.
- clinicians collect blood from a catheter assembly using a needle and syringe that is inserted into the catheter to withdraw blood from a patient through the inserted catheter.
- needles and vacuum tubes as intermediate devices from which the collected blood sample is typically withdrawn prior to testing.
- a blood sampling and collection assembly that can be used to collect a blood sample for traditional laboratory testing and a second sample for point-of-care testing.
- a biological fluid sampling device such as a blood sampling device, includes a housing enclosing a biological fluid reservoir defining an interior, and an access lumen extending from a portion of the housing and establishing fluid communication between the separate vascular access device and the interior of the reservoir.
- the device also includes an outflow lumen extending from a portion of the housing, with the outflow lumen having a first end provided in fluid communication with the interior of the reservoir and a second end.
- the device also includes a vented cap removably disposed over the second end of the outflow lumen, the vented cap comprising a gas permeable vent in gaseous communication between the interior of the reservoir and an ambient environment, wherein the interior of the reservoir contains a sample stabilizer.
- the device also includes a luer lock at least partially surrounding the access lumen.
- the vented cap may include a luer lock for insertion in the outflow lumen.
- the vented cap may also include a fastener for removably connecting a portion of the cap to a portion of the housing.
- the interior of the reservoir may be configured for receiving a fluid sample therein.
- the housing may also include a compressible portion and compression of the compressible portion may expel a fluid sample from the interior of the reservoir through the access lumen.
- the access lumen is disposed at a distal end of the housing and the outflow lumen is disposed at a proximal end of the housing.
- the housing may have a visual identifier which corresponds to a specific sample stabilizer.
- the visual identifier may be a specific color.
- the vent may include at least one of a porous plug, a permeable membrane, and small vent holes.
- a biological fluid sampling and collection assembly such as a blood sampling and collection assembly, may include a biological fluid sampling device.
- the biological fluid sampling device includes a housing enclosing a biological fluid reservoir defining an interior, and an access lumen extending from a portion of the housing and establishing fluid communication between a separate vascular access device and the interior of the reservoir.
- the device may also include an outflow lumen extending from a portion of the housing, with the outflow lumen having a first end provided in fluid communication with the interior of the reservoir and a second end.
- the assembly may also include a sample collection device including an adapter for accessing an interior of a sample container and for establishing fluid communication between the biological fluid reservoir and an interior of the sample container.
- the sample collection device may also include a flow restrictor engaged with the adapter.
- the flow restrictor may be transitionable from an open position, in which fluid communication is permitted between the biological fluid reservoir and the interior of the sample container, to a closed position, in which the biological fluid reservoir is in fluid isolation from the interior of the sample container, wherein the interior of the reservoir contains a sample stabilizer therein.
- the biological fluid reservoir contains a fluid and when the flow restrictor is in the open position, the fluid passes from the biological fluid reservoir to the interior of the sample container.
- the flow restrictor is in the open position when the sample container is engaged with the adapter, and the flow restrictor is in the closed position when the sample container is removed from the adapter.
- the assembly further includes a vented cap removably disposed over the second end of the outflow lumen.
- the vented cap includes a gas permeable vent in gaseous communication between the interior of the reservoir and an ambient environment.
- the sample container may be a vacuum evacuated container.
- the assembly may further include the separate vascular access device in fluid communication with the access lumen.
- the assembly includes an adapter connected between the separate vascular access device and the biological sampling device.
- the adapter may include a housing, a main lumen enclosed within the housing having a main outflow port, a side port including a side lumen extending from and in fluid communication with the main lumen, and a valve transitionable from a first position in which fluid flow is permitted through the main lumen and fluid flow is prevented through the side lumen, to a second position in which fluid flow through both the main lumen and side lumen is permitted.
- the valve may be transitioned from the first position to the second position by insertion of a tubular member into the side lumen through the side port.
- the present invention relates to a biological fluid sampling device, such as a blood sampling device 110, used to collect a blood sample for use in point-of-care testing and analysis.
- the blood sampling device 110 is configured as part of a larger extravascular system 10, and is configured to receive the fluid sample from a separate vascular access device 12.
- An exemplary extravascular system is depicted in FIG. 1 .
- the system includes the blood sampling device 110, a sample container collection device 112, and the vascular access device 12.
- the vascular access device 12 may include numerous components such as an intravascular needle 14, an over-the-needle catheter 16, and needle shielding structure 18, as well as integrated extension tubing 20 terminating in a luer access adapter 22 or port, as is known in the art.
- Exemplary vascular access devices include both straight and ported intravenous catheters such as the AUTOGUARDTM shielded catheter commercially available from Becton, Dickinson, and Company, integrated peripheral intravenous catheters, winged needle sets, and blood collections sets.
- An IV access set such as the BD NEXIYATM Closed Intravenous (IV) Catheter System commercially available from Becton, Dickinson, and Company may also be used to create a closed access system.
- an enclosed luer adapter port such as the BD Q-SYTETM Luer Access Split Septum, also commercially available from Becton, Dickinson, and Company, may be used to entirely enclose the luer access adapter 22 between the sampling device 110 and vascular access device 12.
- the sampling device 110 may be directly connected to an intravenous catheter hub, without additional components such as extension tubing 20, to reduce the number of components and simplify the collection and sampling process.
- the vascular access device 12 may further include a flow restrictor, such as a clamp 24, to restrict blood flow through the extension tubing 20 when the sampling device 110 and/or collection device 112 are removed from the extravascular system 10.
- the luer access adapter 22 may include an integral valve or septum which automatically closes to restrict fluid flow after the sampling device 110 is removed from the extravascular system 10.
- the present invention is intended to include various modular components which can be combined to form numerous extravascular systems based on the types of blood samples to be collected. It is also intended herein, that an integrated unit of both the luer access adapter 22 and the sampling device 110 may be provided within the scope of the present invention.
- Alternative configurations of an extravascular system 10, within the scope of the present invention and including multiple blood sampling devices and/or specimen container collection devices, are depicted in FIGS. 8 and 13 .
- the blood sampling device 110 includes a housing body 114, which may be formed by injection molding or blow molding, and a removeable vented end cap 116 as shown in FIG. 2 .
- the blood sampling device 110 can, in some cases, reduce the number of components required to draw a diagnostic blood sample from a patient. This is because the blood sampling device 110 combines the ability to perform the processes of venting the extravascular system and obtaining a blood sample into a single device. More specifically, the blood sampling device 110 is configured to vent air from the extravascular system 10, thereby drawing blood from the vascular access device 12 through extension tubing 20 to the sampling device 110. External power sources such as motorized pumps, as are known in the art, may also be used to push blood through the extravascular system 10 to the sampling device 110.
- the blood sampling device 110 may also receive blood via a wicking means disposed within a distal end of the device, for drawing blood into the device. The blood is retained within a reservoir 118, as shown in FIG. 4 , of the sampling device 110.
- test strips, glass slides, and diagnostic cartridges are point-of-care testing devices that receive a blood sample and test that blood for one or more physiological and biochemical states.
- testing cartridges include the i-STAT® testing cartridge commercially available from the Abbot group of companies. Testing cartridges such as the i-STAT® cartridges may be used to test for a variety of conditions including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. The results of tests using such cartridges are quickly provided to the clinician.
- the housing body 114 of the biological sampling device 110 includes a narrow tubular portion 120 having an access lumen 122 configured to establish fluid communication with the separate vascular access device 12.
- the narrow tubular portion 120 may be a male luer lock connection 124 adapted for insertion into the female luer access adapter 22 of the vascular access device 12.
- the reservoir 118 is enclosed within the housing body 114 and includes an internal volume sufficient to contain enough blood for use in a diagnostic test, for example, an internal volume of between about 0.1 mL and about 10 mL.
- the reservoir 118 is sized to retain a quantity of blood needed for a specific test or a specific number of tests.
- the interior of the reservoir contains a sample stabilizer therein.
- the reservoir 118 may be provided with various sample stabilizers, such as blood preservatives, reagents, or anti-coagulants (e.g., heparin) to maintain the blood and to ensure its usefulness for certain intended blood tests.
- the housing body 114 of the blood sampling device 110 may be provided as a specific color to signal to a user that the reservoir 118 of the sampling device 110 includes the blood preserving chemical. Blood sampling devices without the preservative may have a different housing body color to signal to the user that the blood sampling device does not include such chemicals.
- the reservoir 118 is in fluid communication with both the access lumen 122 and an outflow lumen 126, generally disposed on an opposite end of the housing body 114 from the access lumen 122.
- the outflow lumen 126 may be enclosed by a connection structure such as a threaded port 128. As shown in the embodiments depicted in FIGS. 2-4 , the threaded port 128 and outflow lumen 126 are connected to the removable end cap 116.
- the removable cap 116 is configured to be attached to the threaded port 128 and includes an inner channel 130 extending through a portion of the end cap 116 which is in fluid communication with the outflow lumen 126 and reservoir 118.
- the inner channel 130 is provided with a gas permeable vent 132 which permits gas to pass therethrough but which prevents passage of a fluid such as blood.
- the vent 132 may include various structures capable of providing these properties, such as porous plugs, permeable membranes, and/or structures containing a plurality of small venting holes.
- the vent 132 may include a permeable portion formed from a combination of glass, polyethylene terephthalate (PET), microfiber material, and/or other synthetic materials made of high-density polyethylene fibers.
- the vent 132 may be hydrophobic or hydrophilic.
- the vent 132 may include layers of different materials to enable the vent 132 to be both hydrophobic and air permeable.
- the sampling device 110 may be removed from the extravascular system 10.
- a clamp 24 may be closed to restrict further blood flow through the extension tubing 20 before removing the sampling device 110.
- the extravascular system 10 may include a valve or septum for automatically restricting fluid flow from the vascular access device 12 once the sampling device 110 is removed.
- the blood sampling device 110 is configured to eject at least a portion of the collected blood sample from the reservoir 118.
- the blood sampling device 110 includes a compressible portion 134.
- the housing body 114 is formed from a flexible or semi-flexible material such that the entire housing body 114 is compressible.
- the compressible portion 134 may only include a smaller section of the housing body 114 which flexes when pressed.
- the compressible portion 134 may include ridges or other gripping members 136 to facilitate gripping, holding, and manipulation by a user.
- the compressible portion 134 is disposed between two substantially rigid sections, such that the compressible portion 134 compresses when the rigid sections are pressed by a user.
- the rigid portions provide structural strength and stability for the sampling device 110.
- the compressible portion 134 of the housing body 114 may be achieved by thinning the wall of the housing body 114 to increase flexibility.
- the housing body 114 may be formed by a two-shot molding technique in which a flexible material is overmolded around a distal section of the housing body 114. In either case, the compressible portion 134 is more flexible than the rigid sections and configured to deflect inwardly toward the reservoir 118.
- the sampling device 110 is configured to retain blood when uncompressed and to eject an amount of blood when compressed.
- blood is naturally retained within the reservoir 118 of the blood sampling device 110 until the compressible portion 134 is compressed by a clinician.
- the longitudinal length of the tubular portion 120 and perimeter distance of the access lumen 122 are chosen so that when pressure is within a certain range, blood is retained within the reservoir 118.
- the pressure is increased beyond the retention range and blood is permitted to flow from the sampling device 110 through the access lumen 122.
- the blood can be ejected to a point-of-care testing device 30, such as a blood test strip, diagnostic cartridge, or onto another type of blood testing/analysis device.
- the sampling device 110 may include multiple chambers within the reservoir 118. Each chamber may have an individual corresponding compressible portion 134 for dispensing only the fluid contained in the respective chamber. In this way, the sampling device 110 may contain individual samples useful for different types of testing. For example, the chambers may have different volumes as needed for particular tests. Additionally, some chambers may include chemicals, blood preservatives, or specific reagents for specific testing needs.
- the compressible portion 134 of the sampling device 110 may be used to assist in drawing blood from the vascular access device 12 into the reservoir 118.
- a user may "pump" the compressible portion 134 of the sampling device 110 to assist in pulling the blood sample into the reservoir 118.
- the removable end cap 116 of the blood sampling device 110 is removed and the sampling device 110 is instead connected to the sample container collection device 112 through the threaded port 128 and outflow lumen 126.
- the sample container collection device 112 may be a vacuum tube collection system (e.g., a Vacutainer).
- a sample container 138 may be a vacuum evacuated test tube having a pierceable closure or other suitable medical container, as is known in the art.
- the sample container collection device 112 is configured to establish fluid communication between the separate vascular access device 12 and the sample container 138 through the sampling device 110 so that the sample container 138 may be filled with a blood sample.
- the container when the container is a vacuum evacuated tube, the pressure difference between the interior of the tube and the extravascular system 10 can assist in drawing fluid through the extravascular system 10 and into the sample container 138.
- the filled sample container 138 may be sent to a clinical laboratory for performing certain blood tests as is commonly done in the healthcare industry.
- the sample container collection device 112 includes a generally cylindrical body 140 having a fastener 142 for connecting the collection device 112 to the body of the sampling device 110.
- the collection device 112 may be configured to attach to the threaded port 128 of the sampling device 110 through a corresponding threaded cap 144.
- the cylindrical body 140 defines an interior region 146 having an open end 148 which receives the sample container 138.
- a filling adapter 150 extends within the interior region 146 from the threaded cap 144, positioned at the base of the collection device 112, into the interior region 146.
- the filling adapter 150 may include an elongated needle cannula 152 having a sharpened tip 154 for piercing a closure 139 of the sample container 138.
- the collection device 112 is configured such that the sample container 138 is inserted through the open end 148 of the interior region 146, closure 139 side first, and brought into contact with the needle tip 154 of the filling adapter 150.
- the tip 154 of the needle cannula 152 may be permitted to pierce the closure 139 to access an interior volume of the sample container 138. In this way, blood is permitted to flow from the vascular access device 12, through the sampling device 110, and through the filling adapter 150 into the internal volume of the sample container 138, thereby filling the sample collection container 138.
- a flow restrictor such as a septum 156 is disposed within a lumen of the filling adapter 150.
- the septum 156 is transitioned to the open position to permit fluid to pass therethrough for filling the sample container 138.
- the septum 156 is permitted to transition to the closed position, thereby blocking fluid access through the needle cannula 152. It is noted that the septum 156 functions in a similar manner to the vented end cap 116 of the embodiment of the sampling device 110 described above.
- the septum 156 when the septum 156 is in the open position, with an evacuate tube connected to the device, air is allowed to vent from the system into the vacuum tube or sample collection container such that air within the extravascular system 10 is vented from the extravascular system 10 through the needle cannula 152.
- the valve 156 When the valve 156 is in the closed position, fluid flow and air is restricted, thereby preventing air from vacating the system and blood from filing the sampling device.
- the adapter 150 when the adapter 150 is connected with a blood sampling device, the blood sampling device is filled with blood via a vacuum tube upon connection with the adapter.
- the sampling device 110 and connected collection device 112 can be removed from the extravascular system 10. Blood can be ejected through the access lumen 122 of the sampling device 110 for testing and analysis according to the process described above.
- the reservoir 118 and access lumen 122 are configured to retain blood within a predetermined fluid pressure range.
- the compressible portion of the sampling device 110 is deflected inwardly toward the reservoir 118, the pressure within the reservoir 118 is increased, thereby causing the fluid to be ejected from the sampling device 110 through the access lumen 122.
- the blood is prevented from being ejected through the outflow lumen 126 by the closed septum 156.
- FIGS. 8-10 a further embodiment of an extravascular system 10 including the vascular access device 12 having a through-portion 210 and a side port 212 is depicted.
- the through portion 210 includes a main outflow port 214 in addition to the side port 212.
- the main outflow port 214 and/or the side port 212 may include female luer lock connections configured to receive a corresponding narrow tubular portion 120 of a blood sampling device 110, as is depicted in FIG. 8 .
- blood samples may be collected for different types of testing and analysis.
- the sampling devices 110 may be configured to collect different volumes of blood.
- one blood sampling device 110 may include a preservative or anticoagulant for modifying the composition of the collected blood while the second sampling device 110 may not include any such chemical components.
- the side port 212 may be used to access a blood sample which the blood sampling device remains connected to the adapter and the vascular access device.
- the sampling device 110 which is free of preservative chemicals, may be connected to the sample container collection device 112.
- a blood sample having a preservative for point-of-care testing, a blood sample without a preservative for additional point-of-care testing, and a blood sample contained within a sample container 138 for conventional laboratory testing may be collected at the same time through the same vascular access device 12. There is no need for additional finger pricks or needle insertions to obtain the required samples from the patient.
- the sampling devices 110 may be color coded so that a user can easily distinguish which sampling device 110 includes additional preserving chemicals and which sampling device does not.
- the through portion 210 includes a main lumen 216 extending from the luer access adapter 22 of the main outflow port 214 and the blood sampling device 110 also includes a side lumen 218 extending to the side outflow port 212.
- the device may further include an internal transitionable valve 220. As shown in FIG. 11 , the valve 220 is configured so that in the unbiased, closed position, fluid flow through the main lumen 216 from the luer access adapter 22 to the main outflow port 214 is permitted; fluid flow through the side lumen 218 to the side port 212 is prevented.
- valve 220 is transitioned to a second position when the narrow tubular portion 120 and access lumen 122 of the sampling device 110 are inserted into the side port 212. More specifically, the narrow tubular portion 120 contacts a portion of the valve 220 and pushes the valve 220 out of the way. When the valve 220 is pushed out of the way, fluid communication between the main lumen 216 and side lumen 218 is established thereby permitting the sampling device 110, inserted through the side port 212, to fill with blood for testing.
- a further embodiment of the extravascular system 10 is depicted including both the main outflow port 214 and the side port 212 connected to sampling devices 110 with end caps 116 affixed thereto.
- the sampling devices 110 are not connected to a sample container collection device 112 as was depicted in FIG. 8 .
- the sampling devices 110 can be filled and used for different testing and analysis procedures.
- one sampling device 110 may include a preservative chemical and the other may not.
- the sampling devices 110 may be color coded to clarify which sampling device is intended for use in which testing or analysis procedure.
- a clinician establishes a vascular access site on a patient using any known means for establishing such access such as a needle 14, catheter 16, or blood collection set as is known in the art.
- the needle 14 and/or catheter 16 may include a shielding structure 18 for shielding a user from the needle 14 as well as other safety structures as are known in the art.
- Extension tubing 20 is connected to the vascular access device 12 and extends from the vascular access site to an open end of the tube having a port or luer access adapter 22.
- the luer access adapter 22 may include a valve or septum 156 to prevent flow of fluid from the access site when the luer access adapter 22 is not connected to another device.
- the tubing may have a flow restrictor, such as a clamp 24, which can be manually transitioned from a fluid allowing a position in which fluid flow is restricted. The clinician can transition the clamp 24 as necessary to perform the desired procedure.
- the clinician inserts the narrow tubular portion 120 of the sampling device 110 into the female luer access adapter 22 of the vascular access device 12 to establish fluid communication between the vascular access device 12 and sampling device 110.
- the sampling device 110 is provided with the vented end cap 116 already attached. As blood is drawn into the extravascular system 10, air within the system is vented through the end cap 116, thereby drawing blood toward the sampling device 110.
- the sampling device 110 may be provided with a sample container collection device 112 attached thereto. In that case, air is vented through the sampling device 110 and exits the extravascular system 10 through the needle cannula 152 of the collection device 112.
- a collection device 112 is connected to the extravascular system 10, the clinician will permit blood to flow through the sampling device 110 and into the sample container 138.
- the sample container 138 is removed from the collection device 112. Removing the sample collection container 138 causes the septum 156 of the collection device 112 to seal, thereby preventing further flow of blood through the needle cannula 152.
- the clinician may insert additional sample containers 138 on the collection device 112 to collect additional blood samples. Once the required number of sample containers 138 is filled, the septum 156 is closed and blood collects in the reservoir 118 of the sampling device 110.
- the next step is removing the sampling device 110 from the vascular access device 12.
- the clinician before removing the sampling device 110, the clinician must close the flow restrictor or clamp 24 to prevent additional fluid flow through the extension tubing 20.
- the female luer access adapter 22 may include an automatically closeable valve or septum 156 which closes to prevent further fluid flow through the extravascular system 10.
- blood is retained within the reservoir 118 of the sampling device 110 by the surface tension of the blood relative to the inner peripheral wall of the access lumen 122.
- the clinician then moves the sampling device 110 to a point-of-care testing device 30 such as a test strip. As is shown in FIG.
- the clinician compresses the sampling device 110 causing the compressible portion 134 to deflect inwardly toward the reservoir 118, thereby reducing the inner volume of the reservoir 118 and increasing the fluid pressure within the reservoir 118.
- a portion of the blood contained in the reservoir 118 is ejected from the reservoir 118 through the access lumen 122 and narrow tubular portion 120 of the sampling device 110.
- the ejected blood is permitted to collect on the test strip or within the diagnostic testing cartridge.
- the clinician may then analyze the blood sample using the point-of-care testing device 30 and record relevant results for further analysis.
- the present blood sampling device 110 significantly reduces the number of components required in order to obtain a diagnostic blood sample following vascular access using an IV or similar blood collection set.
- embodiments of the blood sampling device 110, specimen container collection device 112, and extravascular system 10 may be used to obtain, prepare, and directly test blood samples during normal process of venous access.
- the extravascular system 10 may also be used to fill a standard sample container 138 to send to a laboratory for traditional testing. These embodiments facilitate the entire blood sampling process for clinicians by reducing the number of process steps and reducing the amount of time between sampling and obtaining test results.
- point-of-care testing devices 30 include test strips, glass slides, diagnostic cartridges, or other testing devices for testing and analysis.
- Test strips, glass slides, and diagnostic cartridges are point-of-care testing devices 30 that receive a blood sample and test that blood for one or more physiological and biochemical states.
- Testing cartridges such as the i-STAT® cartridges may be used to test for a variety of conditions including the presence of chemicals and electrolytes, hematology, blood gas concentrations, coagulation, or cardiac markers. The results of tests using such cartridges are quickly provided to the clinician.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Physics & Mathematics (AREA)
- Pathology (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Biophysics (AREA)
- Medical Informatics (AREA)
- Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Manufacturing & Machinery (AREA)
- Vascular Medicine (AREA)
- Biochemistry (AREA)
- Immunology (AREA)
- General Physics & Mathematics (AREA)
- Dermatology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Clinical Laboratory Science (AREA)
- Anesthesiology (AREA)
- Medicinal Chemistry (AREA)
- Food Science & Technology (AREA)
- Urology & Nephrology (AREA)
- Ecology (AREA)
- Diabetes (AREA)
- Cardiology (AREA)
- Sampling And Sample Adjustment (AREA)
- Investigating Or Analysing Biological Materials (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361811918P | 2013-04-15 | 2013-04-15 | |
PCT/US2014/033920 WO2014172232A1 (en) | 2013-04-15 | 2014-04-14 | Medical device for collection of a biological sample |
Publications (2)
Publication Number | Publication Date |
---|---|
EP2986216A1 EP2986216A1 (en) | 2016-02-24 |
EP2986216B1 true EP2986216B1 (en) | 2017-11-22 |
Family
ID=51704181
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP14722948.8A Active EP2986216B1 (en) | 2013-04-15 | 2014-04-14 | Medical device for collection of a biological sample |
Country Status (9)
Country | Link |
---|---|
US (1) | US10238325B2 (zh) |
EP (1) | EP2986216B1 (zh) |
JP (1) | JP6568843B2 (zh) |
CN (2) | CN104107054B (zh) |
BR (1) | BR112015026154B1 (zh) |
CA (1) | CA2909186C (zh) |
ES (1) | ES2660433T3 (zh) |
MX (1) | MX2015014472A (zh) |
WO (1) | WO2014172232A1 (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2024044238A1 (en) * | 2022-08-24 | 2024-02-29 | Becton, Dickinson And Company | Blood culture sample collection system |
Families Citing this family (29)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2013202778A1 (en) * | 2013-03-14 | 2014-10-02 | Gen-Probe Incorporated | Systems, methods, and apparatuses for performing automated reagent-based assays |
JP6568843B2 (ja) * | 2013-04-15 | 2019-08-28 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | 体液サンプリングデバイス、並びに体液サンプリングおよび採取アセンブリ |
US20160073937A1 (en) * | 2014-09-11 | 2016-03-17 | Becton, Dickinson And Company | Blood sampling system for improving draw success and reducing hemolysis |
US9649061B2 (en) * | 2015-03-10 | 2017-05-16 | Becton, Dickinson And Company | Biological fluid micro-sample management device |
EP3603513B1 (en) | 2015-06-19 | 2021-12-22 | Becton, Dickinson and Company | Biological fluid collection device |
ES2942580T3 (es) | 2015-08-06 | 2023-06-02 | Becton Dickinson Co | Dispositivo de recogida de fluidos biológicos |
JP2018536142A (ja) * | 2015-09-01 | 2018-12-06 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | 試料の相を分離するためのデプスフィルトレーションデバイス |
ES2846863T3 (es) | 2015-12-11 | 2021-07-29 | Babson Diagnostics Inc | Recipiente para muestras y método para separar suero o plasma de la sangre completa |
EP4059556A1 (en) | 2017-03-21 | 2022-09-21 | Velano Vascular, Inc. | Methods for controlling catheter device size |
CN110430914B (zh) | 2017-03-21 | 2022-03-01 | 威蓝诺血管股份有限公司 | 通过已放置的外周静脉导管进行流体输送的装置 |
CN108929841A (zh) * | 2017-05-25 | 2018-12-04 | 菏泽学院 | 动物生理实验用质粒dna样品手动制作装置 |
USD861161S1 (en) * | 2017-06-22 | 2019-09-24 | Kpr U.S., Llc | Connector |
US11291802B2 (en) * | 2017-10-09 | 2022-04-05 | Becton, Dickinson And Company | Fluid storage unit, systems, and methods for catheter priming |
ES2962757T3 (es) * | 2018-02-06 | 2024-03-21 | Becton Dickinson Co | Sistema de recogida y estabilización de fluidos biológicos |
KR20240019404A (ko) * | 2018-02-26 | 2024-02-14 | 벡톤 디킨슨 앤드 컴퍼니 | 수집 모듈 |
CA3097105A1 (en) * | 2018-04-17 | 2019-10-24 | Becton, Dickinson And Company | Biological fluid collection system |
EP4331486A3 (en) * | 2018-05-14 | 2024-04-03 | Loop Medical SA | Sample collection device, system and method for extracting and collecting a sample of a fluid of a user |
CN112312876A (zh) * | 2018-05-22 | 2021-02-02 | 美国血液技术公司 | 无密封件血浆瓶及其顶盖 |
BR112021002856A2 (pt) * | 2018-08-17 | 2021-05-11 | Becton, Dickinson And Company | sistema de coleta de fluido biológico e conjunto de estabilização |
WO2020206047A1 (en) * | 2019-04-01 | 2020-10-08 | Kurin, Inc. | Non-venting bodily fluid sample optimization device and system |
AU2020333843A1 (en) | 2019-08-20 | 2022-03-31 | Velano Vascular, Inc. | Fluid transfer devices with extended length catheters and methods of using the same |
US20210069483A1 (en) * | 2019-09-10 | 2021-03-11 | Becton, Dickinson And Company | Vascular Access Device Adapter |
CN111141902A (zh) * | 2020-01-21 | 2020-05-12 | 佘钊炜 | 凝血检测装置 |
US20220047195A1 (en) * | 2020-08-14 | 2022-02-17 | Becton, Dickinson And Company | Blood Collection Device and Related Systems and Methods |
KR20230070474A (ko) * | 2020-09-21 | 2023-05-23 | 벡톤 디킨슨 앤드 컴퍼니 | 에어 프라이밍을 용이하게 하기 위한 채혈 장치, 시스템 및 방법 |
US20230255529A1 (en) * | 2022-02-14 | 2023-08-17 | Becton, Dickinson And Company | Point of Care Collection and Transfer Device with Luer Lock Access Device and Syringe Compatibility |
US20230277808A1 (en) * | 2022-03-04 | 2023-09-07 | Becton, Dickinson And Company | Non-Integrated Catheter and Extension Set System and Methods for Collection of a Blood Culture Sample |
US20230277105A1 (en) * | 2022-03-07 | 2023-09-07 | Becton, Dickinson And Company | Blood Access Device with Integrated Blood Diagnostics |
WO2023172538A2 (en) * | 2022-03-08 | 2023-09-14 | Becton, Dickinson And Company | Small sample collection and dispensing device for use with luer lock access device and point-of-care diagnostics |
Family Cites Families (79)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3322114A (en) | 1964-07-01 | 1967-05-30 | Hynson Westcott & Dunning Inc | Apparatus for securing a sample of blood plasma for testing |
US3640388A (en) | 1970-08-20 | 1972-02-08 | Damon Corp | Dialyzing liquid-collecting container |
US4134512A (en) | 1977-06-08 | 1979-01-16 | Becton, Dickinson And Company | One-way evacuated tube stopper |
US4511349A (en) | 1982-07-06 | 1985-04-16 | Beckman Instruments, Inc. | Ultracentrifuge tube with multiple chambers |
US4627445A (en) | 1985-04-08 | 1986-12-09 | Garid, Inc. | Glucose medical monitoring system |
US5046509A (en) | 1988-12-30 | 1991-09-10 | Spacelabs, Inc. | Device for the conditioning, handling and measurement of blood |
JPH0778025B2 (ja) | 1990-03-20 | 1995-08-23 | 日本赤十字社 | 免疫グロブリンgの製造方法 |
US5055203A (en) | 1990-05-22 | 1991-10-08 | Eastman Kodak Company | Blood collection device with reduced serum dispensing volume and integral needle |
JP3130547B2 (ja) | 1991-02-28 | 2001-01-31 | テルモ株式会社 | 血液バッグ |
US5163442A (en) | 1991-07-30 | 1992-11-17 | Harry Ono | Finger tip blood collector |
US5231993A (en) | 1991-11-20 | 1993-08-03 | Habley Medical Technology Corporation | Blood sampler and component tester with guide member |
US5726026A (en) | 1992-05-01 | 1998-03-10 | Trustees Of The University Of Pennsylvania | Mesoscale sample preparation device and systems for determination and processing of analytes |
US5422018A (en) | 1994-01-31 | 1995-06-06 | Applied Imaging | Centrifuge tube and adaptor |
US5636640A (en) | 1995-02-06 | 1997-06-10 | Volunteers For Medical Engineering | Liquid sampling and test apparatus |
US6074183A (en) | 1995-02-09 | 2000-06-13 | First Medical, Inc. | Peristaltic system and method for plasma separation and blood dispensation |
US5839715A (en) | 1995-05-16 | 1998-11-24 | Alaris Medical Systems, Inc. | Medical adapter having needleless valve and sharpened cannula |
US6241886B1 (en) | 1995-06-09 | 2001-06-05 | Toyo Boseki Kabushiki Kaisha | Plasma separation filter |
US5856174A (en) | 1995-06-29 | 1999-01-05 | Affymetrix, Inc. | Integrated nucleic acid diagnostic device |
US6506167B1 (en) | 1997-12-24 | 2003-01-14 | I-Design Co., Ltd. | Blood-collecting tubes |
US6948843B2 (en) | 1998-10-28 | 2005-09-27 | Covaris, Inc. | Method and apparatus for acoustically controlling liquid solutions in microfluidic devices |
US6264619B1 (en) | 1999-09-01 | 2001-07-24 | Becton, Dickinson And Company | Kit for drawing a blood sample |
US6319719B1 (en) | 1999-10-28 | 2001-11-20 | Roche Diagnostics Corporation | Capillary hematocrit separation structure and method |
EP1106065A3 (en) | 1999-11-26 | 2004-03-03 | CellContol Biomedical Laboratories GmbH | Method of and container for storing and transporting vital tissue, fluid or cell materials |
US6869405B2 (en) | 2001-03-30 | 2005-03-22 | Becton, Dickinson And Company | Blunt cannula and filter assembly and method of use with point-of-care testing cartridge |
US20040116830A1 (en) | 2001-08-24 | 2004-06-17 | Trudeau William M | Blood testing deivce |
US7166443B2 (en) | 2001-10-11 | 2007-01-23 | Aviva Biosciences Corporation | Methods, compositions, and automated systems for separating rare cells from fluid samples |
US6949355B2 (en) | 2001-10-11 | 2005-09-27 | Aviva Biosciences | Methods, compositions, and automated systems for separating rare cells from fluid samples |
DE20213607U1 (de) | 2002-02-21 | 2003-07-03 | Hartmann Paul Ag | Blutanalysegerät zur Bestimmung eines Analyten |
JP4191051B2 (ja) | 2002-02-27 | 2008-12-03 | 三光純薬株式会社 | 血漿又は血清分離具 |
US8702624B2 (en) | 2006-09-29 | 2014-04-22 | Sanofi-Aventis Deutschland Gmbh | Analyte measurement device with a single shot actuator |
ATE553797T1 (de) | 2002-08-23 | 2012-05-15 | Caridianbct Inc | Verfahren und gerät zur trennung von blutkomponenten |
KR101005970B1 (ko) | 2002-11-19 | 2011-01-05 | 가부시키가이샤 아이 디자인 | 혈장 또는 혈청 분리막, 및 혈장 또는 혈청 분리막을이용한 필터 장치 |
US20040143226A1 (en) * | 2003-01-16 | 2004-07-22 | Becton, Dickinson And Company | Blood collection set with venting mechanism |
US20070160503A1 (en) | 2003-06-13 | 2007-07-12 | Palaniappan Sethu | Microfluidic systems for size based removal of red blood cells and platelets from blood |
US7488297B2 (en) | 2003-07-30 | 2009-02-10 | Patrice Flaherty | Blood collecting devices |
WO2005018710A2 (en) | 2003-08-20 | 2005-03-03 | Facet Technologies, Llc | Blood sampling device |
US7476326B2 (en) | 2003-09-26 | 2009-01-13 | Ahn Chong H | On-chip sample preparation for whole blood analysis |
US7763209B2 (en) | 2004-03-11 | 2010-07-27 | Handylab, Inc. | Sample preparation device and method |
JP2005287955A (ja) | 2004-04-02 | 2005-10-20 | Sekisui Chem Co Ltd | 真空採血管用栓体及び真空採血管 |
US20050273019A1 (en) * | 2004-06-02 | 2005-12-08 | Becton, Dickinson And Company | Blood collection set with venting mechanism |
JP2004361419A (ja) | 2004-08-26 | 2004-12-24 | Fuji Photo Film Co Ltd | 血液濾過ユニット |
WO2006047831A1 (en) | 2004-11-03 | 2006-05-11 | Agen Biomedical Limited | Detection device and method |
US20090136982A1 (en) | 2005-01-18 | 2009-05-28 | Biocept, Inc. | Cell separation using microchannel having patterned posts |
US8158410B2 (en) | 2005-01-18 | 2012-04-17 | Biocept, Inc. | Recovery of rare cells using a microchannel apparatus with patterned posts |
JP2006288680A (ja) | 2005-04-11 | 2006-10-26 | Enomoto Co Ltd | 採血キット |
US7473216B2 (en) | 2005-04-21 | 2009-01-06 | Fresenius Hemocare Deutschland Gmbh | Apparatus for separation of a fluid with a separation channel having a mixer component |
US20070031283A1 (en) | 2005-06-23 | 2007-02-08 | Davis Charles Q | Assay cartridges and methods for point of care instruments |
AU2007265628B2 (en) | 2006-06-23 | 2012-12-06 | Perkinelmer Health Sciences, Inc. | Methods and devices for microfluidic point-of-care immunoassays |
KR100843339B1 (ko) | 2006-12-07 | 2008-07-03 | 한국전자통신연구원 | 혈액 중의 혈장 분리를 위하여 마이크로채널을 이용한혈장분리기 및 이에 의한 혈장분리방법 |
US8888713B2 (en) * | 2007-03-07 | 2014-11-18 | Becton, Dickinson And Company | Safety blood collection assembly with indicator |
AU2008233220B2 (en) | 2007-03-30 | 2013-01-10 | Instrumentation Laboratory Company | Adaptor for sample vial |
US8267911B2 (en) | 2007-06-08 | 2012-09-18 | Smiths Medical Asd, Inc. | Flow-through fluid reservoir |
CN101332320A (zh) | 2007-06-27 | 2008-12-31 | 上海达华医疗器械有限公司 | 一次性使用离心式血浆分离器 |
JP5433139B2 (ja) | 2007-06-29 | 2014-03-05 | 株式会社東芝 | マイクロ化学分析装置、その測定方法、及びマイクロカセット |
KR101009447B1 (ko) | 2007-11-12 | 2011-01-19 | 바디텍메드 주식회사 | 체액 샘플링, 전처리 및 투입장치 및 방법 |
US9968931B2 (en) | 2007-12-12 | 2018-05-15 | Nan Zhang | Rapid and efficient filtering whole blood in capillary flow device |
FR2929135A1 (fr) | 2008-03-31 | 2009-10-02 | Commissariat Energie Atomique | Dispositif d'aliquotage et de dispense d'un liquide |
WO2009123592A1 (en) | 2008-04-03 | 2009-10-08 | Zyomyx, Inc. | Device and method for analysis of samples with depletion of analyte content |
DE202008010918U1 (de) | 2008-08-15 | 2008-12-24 | Dienst, Michael | Einweg-Spritzensystem auf Blister-Basis zur Entnahme einer Körperblutprobe |
US20100093551A1 (en) | 2008-10-09 | 2010-04-15 | Decision Biomarkers, Inc. | Liquid Transfer and Filter System |
US20100241031A1 (en) | 2009-03-20 | 2010-09-23 | Venture Corporation Limited | Analyte Test Device Integral With Lancet Firing Mechanism |
EP2264453B1 (en) | 2009-06-17 | 2013-04-03 | Leukocare Ag | Method for filtering blood |
US8383044B2 (en) * | 2009-07-09 | 2013-02-26 | Becton, Dickinson And Company | Blood sampling device |
JP2011055916A (ja) | 2009-09-07 | 2011-03-24 | Terumo Corp | 検査用血液容器および採血器具 |
SE534542C2 (sv) | 2009-09-30 | 2011-09-27 | Calmark Sweden Ab | Testsystem för bestämning av hypoxiutlöst cellskada |
CN101695446B (zh) | 2009-10-30 | 2011-01-12 | 天津市百利康泰生物技术有限公司 | 一次性软接带收集容器及放血口的抗凝真空采血针 |
ITTO20100068U1 (it) | 2010-04-20 | 2011-10-21 | Eltek Spa | Dispositivi microfluidici e/o attrezzature per dispositivi microfluidici |
EP2413138B1 (de) | 2010-07-27 | 2020-04-29 | BOEHRINGER INGELHEIM microParts GmbH | Vorrichtung und verfahren zur abtrennung von bestandteilen einer probenflüssigkeit |
US8980106B2 (en) | 2010-12-15 | 2015-03-17 | Abbott Laboratories | Apparatus and method for separation of whole blood into plasma or serum and cells |
ES2557466T3 (es) | 2011-03-09 | 2016-01-26 | Becton Dickinson And Company | Manguito para lanceta extraíble de dispositivo de punción |
WO2012149155A1 (en) | 2011-04-29 | 2012-11-01 | Seventh Sense Biosystems, Inc. | Systems and methods for collecting fluid from a subject |
WO2012149134A1 (en) | 2011-04-29 | 2012-11-01 | Seventh Sense Biosystems, Inc. | Devices and methods for collection and/or manipulation of blood spots or other bodily fluids |
CA2833275C (en) | 2011-04-29 | 2021-06-15 | Seventh Sense Biosystems, Inc. | Delivering and/or receiving bodily fluids |
DE102011078961B4 (de) | 2011-07-11 | 2021-02-18 | Robert Bosch Gmbh | System zum Separieren von Körperflüssigkeitsbestandteilen und Verfahren zum Herstellen eines derartigen Systems |
US9162186B2 (en) | 2011-07-22 | 2015-10-20 | Chromedx Corp. | Sample filtration assembly |
US8852446B2 (en) | 2011-10-03 | 2014-10-07 | Palo Alto Research Center Incorporated | Platelet extraction from blood |
US9358364B2 (en) | 2011-10-06 | 2016-06-07 | Becton, Dickinson And Company | Activator attachment for blood control catheters |
CN102764133A (zh) | 2012-08-10 | 2012-11-07 | 上海科华检验医学产品有限公司 | 一种可直接分离血浆的真空采血管及其方法 |
JP6568843B2 (ja) * | 2013-04-15 | 2019-08-28 | ベクトン・ディキンソン・アンド・カンパニーBecton, Dickinson And Company | 体液サンプリングデバイス、並びに体液サンプリングおよび採取アセンブリ |
-
2014
- 2014-04-14 JP JP2016508994A patent/JP6568843B2/ja active Active
- 2014-04-14 CA CA2909186A patent/CA2909186C/en active Active
- 2014-04-14 WO PCT/US2014/033920 patent/WO2014172232A1/en active Application Filing
- 2014-04-14 EP EP14722948.8A patent/EP2986216B1/en active Active
- 2014-04-14 BR BR112015026154-0A patent/BR112015026154B1/pt active IP Right Grant
- 2014-04-14 US US14/251,672 patent/US10238325B2/en active Active
- 2014-04-14 ES ES14722948.8T patent/ES2660433T3/es active Active
- 2014-04-14 MX MX2015014472A patent/MX2015014472A/es active IP Right Grant
- 2014-04-15 CN CN201410216264.0A patent/CN104107054B/zh active Active
- 2014-04-15 CN CN201420261737.4U patent/CN203988076U/zh not_active Withdrawn - After Issue
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2024044238A1 (en) * | 2022-08-24 | 2024-02-29 | Becton, Dickinson And Company | Blood culture sample collection system |
Also Published As
Publication number | Publication date |
---|---|
CA2909186C (en) | 2019-01-22 |
CA2909186A1 (en) | 2014-10-23 |
CN203988076U (zh) | 2014-12-10 |
EP2986216A1 (en) | 2016-02-24 |
JP2016518921A (ja) | 2016-06-30 |
MX2015014472A (es) | 2016-02-05 |
CN104107054A (zh) | 2014-10-22 |
US20140309551A1 (en) | 2014-10-16 |
US10238325B2 (en) | 2019-03-26 |
JP6568843B2 (ja) | 2019-08-28 |
ES2660433T3 (es) | 2018-03-22 |
BR112015026154A2 (pt) | 2017-07-25 |
BR112015026154B1 (pt) | 2022-05-10 |
CN104107054B (zh) | 2016-06-29 |
WO2014172232A1 (en) | 2014-10-23 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US11291393B2 (en) | Medical device for collection of a biological sample | |
EP2986216B1 (en) | Medical device for collection of a biological sample | |
EP2986219B1 (en) | Biological fluid separation and testing system | |
US9895092B2 (en) | Vented blood sampling device | |
EP3085307B1 (en) | Biological fluid collection device | |
EP2595534B1 (en) | A device and method for collecting a blood sample | |
EP2986380B1 (en) | Biological fluid sampling, separation and testing system |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
|
17P | Request for examination filed |
Effective date: 20151022 |
|
AK | Designated contracting states |
Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
AX | Request for extension of the european patent |
Extension state: BA ME |
|
DAX | Request for extension of the european patent (deleted) | ||
RAP1 | Party data changed (applicant data changed or rights of an application transferred) |
Owner name: BECTON, DICKINSON AND COMPANY |
|
RIC1 | Information provided on ipc code assigned before grant |
Ipc: G01N 33/49 20060101ALI20170426BHEP Ipc: A61M 1/34 20060101ALI20170426BHEP Ipc: B04B 7/08 20060101ALI20170426BHEP Ipc: B01L 3/00 20060101ALI20170426BHEP Ipc: A61B 5/15 20060101AFI20170426BHEP Ipc: A61B 5/157 20060101ALI20170426BHEP Ipc: A61B 5/151 20060101ALI20170426BHEP |
|
GRAP | Despatch of communication of intention to grant a patent |
Free format text: ORIGINAL CODE: EPIDOSNIGR1 |
|
INTG | Intention to grant announced |
Effective date: 20170607 |
|
GRAS | Grant fee paid |
Free format text: ORIGINAL CODE: EPIDOSNIGR3 |
|
GRAA | (expected) grant |
Free format text: ORIGINAL CODE: 0009210 |
|
AK | Designated contracting states |
Kind code of ref document: B1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR |
|
REG | Reference to a national code |
Ref country code: GB Ref legal event code: FG4D |
|
REG | Reference to a national code |
Ref country code: CH Ref legal event code: EP |
|
REG | Reference to a national code |
Ref country code: IE Ref legal event code: FG4D |
|
REG | Reference to a national code |
Ref country code: AT Ref legal event code: REF Ref document number: 947620 Country of ref document: AT Kind code of ref document: T Effective date: 20171215 |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R096 Ref document number: 602014017560 Country of ref document: DE |
|
REG | Reference to a national code |
Ref country code: ES Ref legal event code: FG2A Ref document number: 2660433 Country of ref document: ES Kind code of ref document: T3 Effective date: 20180322 Ref country code: FR Ref legal event code: PLFP Year of fee payment: 5 |
|
REG | Reference to a national code |
Ref country code: NL Ref legal event code: MP Effective date: 20171122 |
|
REG | Reference to a national code |
Ref country code: LT Ref legal event code: MG4D |
|
REG | Reference to a national code |
Ref country code: AT Ref legal event code: MK05 Ref document number: 947620 Country of ref document: AT Kind code of ref document: T Effective date: 20171122 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: NL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: SE Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: LT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: FI Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: NO Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180222 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: LV Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: GR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180223 Ref country code: AT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: RS Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: BG Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180222 Ref country code: HR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: DK Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: CY Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: EE Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: SK Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: CZ Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 |
|
REG | Reference to a national code |
Ref country code: DE Ref legal event code: R097 Ref document number: 602014017560 Country of ref document: DE |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: SM Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: RO Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: PL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 |
|
PLBE | No opposition filed within time limit |
Free format text: ORIGINAL CODE: 0009261 |
|
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT |
|
26N | No opposition filed |
Effective date: 20180823 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MC Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: SI Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 |
|
REG | Reference to a national code |
Ref country code: CH Ref legal event code: PL |
|
REG | Reference to a national code |
Ref country code: BE Ref legal event code: MM Effective date: 20180430 |
|
REG | Reference to a national code |
Ref country code: IE Ref legal event code: MM4A |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: LU Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180414 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: CH Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180430 Ref country code: BE Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180430 Ref country code: LI Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180430 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: IE Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180414 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MT Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20180414 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: TR Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: PT Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: MK Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES Effective date: 20171122 Ref country code: HU Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT; INVALID AB INITIO Effective date: 20140414 |
|
PG25 | Lapsed in a contracting state [announced via postgrant information from national office to epo] |
Ref country code: AL Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20171122 Ref country code: IS Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT Effective date: 20180322 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: FR Payment date: 20230321 Year of fee payment: 10 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: IT Payment date: 20230322 Year of fee payment: 10 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: ES Payment date: 20230502 Year of fee payment: 10 Ref country code: DE Payment date: 20230321 Year of fee payment: 10 |
|
PGFP | Annual fee paid to national office [announced via postgrant information from national office to epo] |
Ref country code: GB Payment date: 20240320 Year of fee payment: 11 |